SARECYCLINE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for sarecycline hydrochloride and what is the scope of patent protection?
Sarecycline hydrochloride
is the generic ingredient in one branded drug marketed by Almirall and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sarecycline hydrochloride has seventy-one patent family members in twenty countries.
One supplier is listed for this compound.
Summary for SARECYCLINE HYDROCHLORIDE
International Patents: | 71 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 42 |
Clinical Trials: | 6 |
Patent Applications: | 12 |
What excipients (inactive ingredients) are in SARECYCLINE HYDROCHLORIDE? | SARECYCLINE HYDROCHLORIDE excipients list |
DailyMed Link: | SARECYCLINE HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SARECYCLINE HYDROCHLORIDE
Generic Entry Date for SARECYCLINE HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for SARECYCLINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Beijing Tiantan Hospital | Phase 2 |
NeuroDawn Pharmaceutical Co., Ltd. | Phase 2 |
Derm Research, PLLC | Phase 4 |
Pharmacology for SARECYCLINE HYDROCHLORIDE
Drug Class | Tetracycline-class Drug |
Mechanism of Action | P-Glycoprotein Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for SARECYCLINE HYDROCHLORIDE
US Patents and Regulatory Information for SARECYCLINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Almirall | SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521-001 | Oct 1, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Almirall | SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521-003 | Oct 1, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Almirall | SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521-002 | Oct 1, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Almirall | SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521-002 | Oct 1, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Almirall | SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521-001 | Oct 1, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Almirall | SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521-003 | Oct 1, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for SARECYCLINE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2010513527 | ⤷ Sign Up | |
European Patent Office | 3574908 | SELS CRISTALLINS D'AMIDE DE L'ACIDE (4S,4AS,5AR,12AS)-4-DIMÉTHYLAMINO- 3,10,12,12A-TÉTRAHYDROXY-7-[(MÉTHOXY(MÉTHYL)AMINO)-MÉTHYL]- 1,11-DIOXO-1,4,4A,5,5A,6,11,12A-OCTAHYDRO-NAPHTACÈNE-2-CARBOXYLIQUE ET PROCÉDÉS D'UTILISATION ASSOCIÉS (CRYSTALLINE SALTS OF (4S, 4AS, 5AR, 12AS)-4-DIMETHYLAMINO-3,10,12,12A-TETRAHYDROXY-7-[(METHOXY(METHYL)AMINO)-METHYL]-1,11-DIOXO-1,4,4A,5,5A,6,11,12A-OCTAHYDRO-NAPHTHACENE-2CARBOXYLIC ACID AMIDE AND METHODS OF USING THE SAME) | ⤷ Sign Up |
Israel | 302749 | תרכובת טטראציקלין, תכשיר פרמצבטי המכיל את התרכובת הטטראציקלין, והתרכובת הטטראציקלין או התכשיר הפרמצבטי לטיפול במצב המגיב לטטראציקלין (A tetracycline compound, a pharmaceutical composition comprising the tetracycline compound, and the tetracycline compound of the pharmaceutical composition for treating a tetracycline responsive state) | ⤷ Sign Up |
European Patent Office | 3488853 | COMPOSÉS DE TÉTRACYCLINE SUBSTITUÉS POUR LE TRAITEMENT DE TROUBLES INFLAMMATOIRES DE LA PEAU (SUBSTITUTED TETRACYCLINE COMPOUNDS FOR TREATMENT OF INFLAMMATORY SKIN DISORDERS) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2008079339 | ⤷ Sign Up | |
Denmark | 2109602 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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